Effect of Timing of Tumor-Treating Fields Plus Short-Course Radiation

Newly Diagnosed Glioblastoma in Patients =70 Years Clinical Trial

— GERAS  

Official title:

Effect of Timing of Tumor-Treating Fields Plus Short-Course Radiation in Elderly Patients With Glioblastoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04218019
• Other study ID #: GERAS
• Status: Withdrawn
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: August 1, 2023

Study information

• Verified date: January 2024
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to assess timing of TTFields use as well as safety, feasibility and preliminary efficacy of treatment with TTFields in elderly patients with newly diagnosed GBM simultaneous to RT/ CRT.

The primary aim of the trial is to establish a safely conducted therapy rate higher than 0.8 in the treatment arm.

Description:

Despite the immense effort made over the years with different treatment modalities, the survival of patients with newly diagnosed GBM is still very poor; no treatment is curative; and the quality of life of patients with this tumor is compromised significantly, not only by their disease but also by side effects of these rigorous treatment plans. Especially in elderly patients, a treatment modality is needed that will improve the results of current standard treatments without further impairing the quality of life of these patients for their limited life span.

The objective is to test the feasibility and timing of treatment with the TTFields device in elderly patients with newly diagnosed GBM simultaneous or subsequent to RT/ CRT.

The primary rationale to conduct this study is to improve treatment in the segment of high-grade brain tumors with the highest medical need.

All procedures regarding TTFields are representing routine clinical care within the approved use of the medical product in Germany; the present trial aims to investigate the optimal timing of TTFields use in elderly GBM patients.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed, newly diagnosed glioblastoma (astrocytoma WHO grade IV)

• Indication for hypofractionated radiotherapy or hypofractionated chemo-radiotherapy with temozolomide

• Open biopsy or resection

• Craniotomy or intracranial biopsy site must be adequately healed

• Informed consent

• Age: >65 years

• KPS =50%

• Ability of subject to understand character and individual consequences of the clinical trial

• Written informed consent of participation

Exclusion Criteria:

• Concurrent participation in another competing interventional clinical trial studying a drug or treatment regimen.

• Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry

• Prior RT of the brain

• Patients who have not yet recovered from acute high-grade toxicities of prior therapies

• MRI or TTFields contraindication (e.g. cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements, certain metal implants, patients with severe skull defects such as a missing bone flap, programmable shunts)

• Known hypersensitivity to conductive hydrogels

• Pregnant and lactating women

Related Conditions & MeSH terms

• Glioblastoma
• Newly Diagnosed Glioblastoma in Patients =70 Years

Intervention

Device:
• TTFields
The NovoTTF-200 A device used in this trial delivers very low intensity, alternating electric fields to the tumor site through the scalp. These fields are known as Tumor Treating Fields or TTFields.

Locations

Country	Name	City	State
Germany	University Hospital of Heidelberg, Radiation Oncology	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Juergen Debus

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safely conducted therapy rate (SCTR)	The proportion of patients fulfilling the inclusion/exclusion criteria who were treated for at least one week according to protocol and neither experienced neither NCI-CTC-AEs of Grade 3 nor 4	at least one week of treatment
Primary	Number of participants with treatment related adverse events as assessed by CTCAE V 5.0.	Safety and tolerability of TTFields Treatment combined with radiotherapy/chemo-radiotherapy	within 31 weeks after treatment
Secondary	Progression-free survival	according to RANO criteria	within 6 month after treatment
Secondary	The correlation between the Optune device usage and the health-related quality of life of elderly patients and families undergoing this therapy in combination with radiotherapy/chemo-radiotherapy.	Score on the EORTC QoL C15-Pal	within 31 weeks after treatment
Secondary	The correlation between the Optune device usage and the health-related quality of life of elderly patients and families undergoing this therapy in combination with radiotherapy/chemo-radiotherapy.	Score on the EORTC QoL BN20	within 31 weeks after treatment